Effect of vaginal application of Unani formulation versus metronidazole in leucorrhoea due to bacterial vaginosis- A randomized controlled trial

Bacterial vaginosis (BV) is a polymicrobial syndrome characterized by a shift in the composition of the vaginal microbiota from ‘optimal’ to ‘non-optimal’ This non-optimal microbiological state involves a reduction in protective lactobacilli, and an increase in bacterial diversity and facultative and strict anaerobes, including Gardnerella spp., Atopobium vaginae, Prevotella spp., and others, referred to as BV-associated bacteria (BVAB).(1) Although the prevalence of bacterial vaginosis differs widely from country to country within the same region and even within similar population groups, it has been estimated to be in the range of 8% to 75%. Bacterial vaginosis can occur in any age group, but globally it is more prevalent in females of reproductive age.(2)  BV is associated with pelvic inflammatory disease, STIs, and risk for human immunodeficiency virus (HIV) infection and transmission.(1–3) BV infection in pregnancy has a poor perinatal outcome, in particular an increased risk of preterm birth, premature rupture of amniotic membranes (PROM) and chorioamnionitis.(4)The number of behavioral and socioeconomic risk factors are cigarette smoking, douching, multiple sexual partners, use of sex toys and sharing of them within the women, use of intrauterine devices (IUD) contraception, drug abuse, early age intercourse, black ethnicity, oral sex, sexually transmitted diseases (STDs) or immune deficiency disorders like HIV, HSV-1 and 2, infection with C. trachomatis, N. gonorrhoeae).(1,2,5,6)

In conventional medicine, metronidazole and clindamycin are the 1st line of treatment.(1,2) Despite the fact that women with BV who get seven days of oral metronidazole (MTZ) have cure rates of about 80% after 30 days, the majority of BV cases reappear after a year. Recurrent BV is defined as ≥3 annual episodes of symptomatic BV requiring antimicrobial therapy (3), which has negative impact on patient emotionally, sexually and socially, impairing their quality of life and causing significant economic burden on health care system. (16) In addition it has many side effects, such as toxicity, hypersensitivity reactions, drug resistance, superinfection etc. Therefore, the need for traditional system of medicine arises to reduce the disease incidence, complications and recurrence with least side effects and cost effective treatment.(1)

In Unani system of medicine, many single drugs and compound formulations are available for the treatment of bacterial vaginosis. One such compound formulation include Mazu (Quercus infectoria Oliv), Rasaut (Berberis volgare DC), Kundur (Boswellia serrata Roxb*),* Samaq (Rhus coriaria L) and Shibb-i-yamāni (Alum)(11) possessing the property of Habis (styptic), Qabid (astringent), Radi‘ (repellent), Dafi‘-i-Jarathim (anti-bacterial), Mujaffif (desiccant) etc.(7)Hence, the present study has been designed to validate the efficacy of aforementioned formulation on scientific parameters in patient with leucorrhoea due to bacterial vaginosis.